Stockwinners Market Radar for February 28, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
JNJ... | Hot Stocks20:03 EST Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. The Food and Drug Administration issued an emergency use authorization for the third vaccine for the prevention of coronavirus disease. The EUA allows Johnson & Johnson's (JNJ) Janssen COVID-19 vaccine to be distributed in the U.S for use in individuals 18 years of age and older. Meanwhile, Johnson & Johnson also announced that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended its single-shot COVID-19 vaccine. The ACIP recommendation will be forwarded to the Director of the CDC and the U.S. Department of Health and Human Services for review and adoption. Johnson & Johnson has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20M people in the U.S. The company plans to deliver 100M single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S. 2. Warren Buffett Berkshire Hathaway's (BRK.A, BRK.B) fourth quarter profits rose, with its net earnings rising to $38.5B, or $23,015 a Class A share equivalent, up almost 23% from the previous year's profit of $29.2B, or $17,909 a share. Operating earnings, which exclude some investment results, rose to $5 billion from $4.4 billion the year before. Buffett also said in his annual shareholder letter to "never bet against America." "In its brief 232 years of existence... there has been no incubator for unleashing human potential like America," he added. "Despite some severe interruptions, our country's economic progress has been breathtaking. Our unwavering conclusion: Never bet against America." Buffett said the conglomerate owns the biggest amount of U.S. assets by value than any other company in the country. Berkshire Hathaway also bought back a record amount of company stock last year. During the fourth quarter, the company bought back about $9B shares for a total 2020 repurchase of $24.7B. Buffett said in his annual shareholder letter that repurchases have continued since year-end and "is likely to further reduce its share count in the future." 3. Ross Stores (ROST) offers shoppers a chance to find overlooked "treasures" among a heap of discards and its stock could offer investors the same opportunity, Teresa Rivas wrote in this week's edition of Barron's. The company has had a tough time during the pandemic and its stock has took a bigger beating, the author noted. But the underperformance means that Ross also has the most to gain as more vaccines are given and reopening accelerates, Rivas added. 4. Twilio (TWLO) is in talks to invest as much as $750M in Carlyle Group's (CG) Syniverse Technologies in a precursor to a public listing, Cara Lombardo and Dana Cimilluca of Wall Street Journal reported, citing people familiar with the matter. The investment will be announced Monday and could be followed in the coming months by a merger between Syniverse and a special-purpose acquisition company, sources told the Journal. Such a deal could value Syniverse around $2B to $3B including debt, they added. The Twilio deal involves a commercial arrangement that would send a significant amount of business to Syniverse, which provides roaming, messaging and other telecommunications services, the sources said. 5. American Electric Power (AEP), Dominion Energy (D), Entergy (ETR), Exelon (EXC), NextEra Energy (NEE), Citigroup (C), Dow (DOW) and Asos (ASOMY) saw positive mentions in this week's edition of Barron's.
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JNJ | Hot Stocks17:41 EST CDC Advisory Committee recommends J&J single-shot COVID vaccine for adults 18+ - Johnson & Johnson announced that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization issued by the U.S. Food and Drug Administration. The ACIP recommendation will be forwarded to the Director of the CDC and the U.S. Department of Health and Human Services for review and adoption. The company's single-shot COVID-19 vaccine received EUA from the FDA on February 27, 2021. The terms of the EUA allow use of the vaccine while more data are gathered. The company plans to file for a Biologics License Application with the FDA later in 2021. Johnson & Johnson has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20M people in the U.S. The company plans to deliver 100M single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S.
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BBIO | Hot Stocks16:14 EST BridgeBio, affiliate Origin Biosciences announce FDA approval of NULIBRY - BridgeBio Pharma and affiliate Origin Biosciences announced the U.S. Food and Drug Administration has approved NULIBRY for Injection as the first therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency Type A. This is the first therapy of its kind. The novel therapy was developed based on BridgeBio's commitment to developing a treatment for MoCD Type A in collaboration with the experts and families in the MoCD Type A community. MoCD Type A is an ultra-rare and progressive condition, known to impact less than 150 patients globally with a median survival of four years. MoCD Type A presents shortly after birth, often with severe encephalopathy and intractable seizures. NULIBRY is a first-in-class approved cPMP substrate replacement therapy. The efficacy of NULIBRY for the treatment of patients with MoCD Type A was established based on data from three clinical trials compared to data from a natural history study. In these studies, NULIBRY or recombinant cPMP reduced the risk of death by 82% compared to the untreated, genotype-matched, historical control group in the natural history study. At three years on study, the probability of survival in NULIBRY or rcPMP-treated patients was 84% compared to 55% for untreated genotype-matched patients in the historical control group at three years. In addition to the survival analysis, treatment with NULIBRY led to a reduction of urine concentrations of S-sulfocysteine, a toxic substance that leads to neurological damage, in patients with MoCD Type A, and the reduction was sustained with long-term treatment over 48 months. Animal studies have identified that NULIBRY has phototoxic potential. NULIBRY was reviewed under Priority Review and received Orphan Drug Designation, Breakthrough Therapy Designation and Rare Pediatric Disease Designation from the FDA. With this approval, the FDA also issued a Rare Pediatric Disease Priority Review Voucher to Origin.
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REGN | Hot Stocks16:09 EST Regeneron announces Phase 2 data evaluating antibody cocktail REGN1908-1909 - Regeneron Pharmaceuticals announced detailed results from a Phase 2 proof-of-concept trial evaluating the investigational antibody cocktail REGN1908-1909 in cat-allergic patients with mild asthma. The trial met the primary endpoint of preventing early asthma reactions. The trial also met key secondary endpoints, including improved lung function and an increased amount of cat allergen that patients could tolerate following a single dose of treatment, from as early as the first assessment conducted at week 1. The results were shared in an oral presentation at the virtual 2021 American Academy of Allergy, Asthma and Immunology Annual Meeting. Cat allergy is primarily caused by exposure to Fel d 1, the major allergen in cat dander produced by all cats. Fel d 1 is spread to surrounding environments through airborne particles that adhere to clothing, carpets and furniture. Patients typically experience rapid onset of mild to severe symptoms including nasal congestion, itchy and watery eyes, chest tightening and wheezing. Currently, cat-induced allergic rhinitis is treated with antihistamines and intranasal corticosteroids with moderate efficacy. Allergen-specific immunotherapy takes 12-24 months to see clinical benefit and is contraindicated for patients with severe or uncontrolled asthma. Importantly, the association between cat allergy and asthma is significant, as more than 50% of cat-allergic patients have co-existing asthma. Although rare, cat allergy in these patients can potentially trigger life-threatening asthma attacks leading to hospitalization. REGN1908-1909 is a novel cocktail of two fully-human monoclonal IgG antibodies, designed to specifically bind and block the Fel d 1 allergen, thus preventing it from binding and triggering the endogenous antibodies that cause allergies. REGN1908-1909 was invented using Regeneron's proprietary VelocImmune technology. The Phase 2 randomized, double-blind proof-of-concept trial enrolled 56 cat-allergic patients with mild asthma who received a single dose of REGN1908-1909 600 mg or placebo delivered subcutaneously. This was followed by a 12-week assessment period during which patients underwent a 4-hour Cat Allergen Challenge at weeks 1, 4, 8 and 12 in an environmental exposure unit where they were exposed to cat allergen and monitored for allergic reactions. In order to establish a baseline, patients were also exposed to the EEU 1 week prior to receiving either REGN1908-1909 or placebo. Patients who took REGN1908-1909 experienced significant improvements during the Cat Allergen Challenge compared to those on placebo, which included: Reduced time to EAR for up to 3 months, improved ability to breathe, and improved cat allergen tolerance. Adverse events occurred in 76% of patients who received REGN1908-1909 and 78% of patients who received placebo. AEs more commonly observed with those receiving REGN1908-1909 included injection site reactions. The use of REGN1908-1909 to treat cat-allergic patients with mild asthma is investigational and its efficacy and safety have not been fully evaluated by any regulatory authority.
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